NCT04139746

Pneumatic Retinopexy for Severe Bullous Retinal Detachment

Pneumatic Retinopexy Preceded by Drainage of Subretinal Fluid for the Treatment of Severe Bullous Retinal Detachment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Università degli Studi di Brescia · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety outcomes of scleral buckling (SB) and drainage-injection-pneumoretinopexy (DIP), a modified pneumatic retinopexy technique, in which, before injecting the gas, the drainage of the subretinal fluid is performed with a simultaneous injection of balanced salt solution (BSS) in the vitreous chamber, for the treatment of severe superior bullous rhegmatogenous retinal detachment (SBRD).

Conditions

• Retina Detachment

Interventions

Type	Name	Description
PROCEDURE	Scleral Buckling	Limbal 360 degrees peritomy of the conjunctiva was performed and the four recti muscles were isolated with 4 silk threads 4-0. A width-2 mm silicone encircling band was placed and sutured with 5-0 mersilene on the 4 quadrants of the sclera. Anterior chamber paracentesis was performed, draining about 0.3 mL of aqueous humour, and a buckle (220, 501, 506, or 516; Mira, Waltham, MA, USA) was sutured over the break. In all cases, the drainage puncture was executed at a distance of 11 mm from the limbus, in the area of greatest amount of subretinal fluid. Soon after the drainage puncture, a balanced salt solution (BSS) injection was performed in order to compensate the escape of the subretinal fluid.
PROCEDURE	Drainage-Injection-Pneumoretinopexy	According to the location of the sub-retinal fluid, a quadrant-flap of conjunctiva was opened. Indirect ophthalmoscopy evaluation was also used intraoperatively to localize the break and the subretinal fluid drainage site: in this area a vicryl 6-0 thread was passed through the sclera, about 9-10 mm posteriorly from the limbus, to facilitate the surgical maneuvers. The drainage puncture was performed 11 mm posteriorly from the limbus, having attention not to perform it directly above the site of the retinal break. In detail, a 2 mm radial sclera incision was created with a 15° disposable knife. The incision was cautiously deepened down to the choroid, which was finally perforated by a lachrymal dilator having a blunt tip. Soon after beginning the subretinal fluid drainage, an injection of BSS was performed in the opposite quadrant of the sclera (4 mm from the limbus) in order to allow an optimal spillage of the subretinal fluid and to flatten the retina.

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-03-01
• Completion: 2019-06-30
• First posted: 2019-10-25
• Last updated: 2019-10-25

Locations

1 site across 1 country: Italy